Guidance Library
Manuals & Guidance
Review Types & Decision Charts / Worksheets
- Determining Engagement in Research
- Projects Not Meeting the Definition of Research
- Not Human Subjects Research Categories
- FLEX Review/Registration Project Research Criteria and Categories
- Exempt Research Categories
- Expedited Research Criteria and Categories
- Office of Human Subjects Research Protections: Human Subject Regulations Decision Charts (includes Exempt categories)
- Human Subject Research Determination Worksheet.
Conduct & Research Activities
- Advertisements
- Benign Behavioral Interventions
- Use of CU Student Email Addresses for Recruitment Purposes in Human Subjects Research
- Compensation in Human Subjects Research
- When Do I Need a DUA
- Guidelines for Documentation of Human Subjects Research
- Regulatory File/Binder Contents
- Informed Consent and Waivers
- Identification Levels and Protection in Research
- FERPA Data De-identification: An Overview of Basic Terms
- Human Subject Data Classification Tool
- How to Work with Egnyte
- Use of Internet Survey Platforms in Research
- IRB Designated Public Data Sets
- Research Participant Rights
- Medical Record/Chart Reviews
Special Populations
- Investigators Using Own Students as Research Subjects.
- Research Conducted in K-12 or Higher Education Schools
Collaborative / Multi-site Research
HIPPA
Quality Improvement/Quality Assurance/Program Evaluation
Frequently Asked Questions
Collaborative/Multi-Site Research
Campbell University researchers may engage in collaborative research with individuals and organizations outside of Campbell University. Often circumstances require agreements between collaborators to be in place prior to conducting research activities with human subjects.
Examples of research agreements include:
- Institutional Authorization Agreement (IAA)
- Individual Investigator Agreement (IIA)
- Letters of Support
- Other Collaborations such as Data Use Agreements
Please see IRB Guidance: Collaborative Research for detailed information on each type of agreement.
If you have any questions, please contact the IRB Office.
If you human subjects research is funded or sponsored, the IRB Office must ensure the research activities described in the grant/funding proposal are consistent with the information in your protocol submission. In order to avoid delays in award set-up and access to funds, it is imperative that awards administered by the Office of Research & Sponsored Programs (ORSP) be formally associated with an approved human subjects protocol.
- To associate funding during the initial review of the protocol, submit Funding and Sponsorship Form and the human subjects portion of the grant proposal with the initial review materials.
- To associate funding with an existing protocol, submit a Funding and Sponsorship Form and the human subjects portion of the grant proposal along with the Amendment Submission Form materials. If the addition of funding alters previously approved human subjects research activities, the amendment submission must include revised protocol information and materials, as applicable. Any proposed changes to previously approved research must be reviewed and approved prior to conducting the research activities and before the award can be released.
- If participant involvement in your sponsored research is yet to be defined, please contact the IRB Office for specific instructions.
If you have questions, please contact the IRB Office.
Research Records
Research records must be maintained for at least three years after completion of the research and must be accessible for inspection or audit. Other regulation or requirements may apply to the retention of records, for a longer period of time, such as HIPAA or project sponsor requirements.
Documentation of IRB approval documents, the approved Research Plan, informed consent documents (without a link to data), and all source materials related to the conduct of the research should be maintained unless the IRB has waived the requirement for informed consent or the requirement of documentation of informed consent.
If you have any questions, please contact the IRB Office.
Informed Consent Process & Documentation of Consent and Waivers/Exception of Informed Consent
The requirements for the informed consent process and documentation of consent differ for Registration/Exempt determined research and Expedited/Full approved research. The term “informed consent” refers to both the informed consent process and the documentation of consent. “Documentation of consent” refers to obtaining the signature of the research individual on the consent form. The consent form is part of the informed consent process.
All research protocols must include a consenting process, unless waived by the IRB.
Additional Resources:
- IRB Guidance: Informed Consent and Waivers
- IRB SOP: Informed Consent Process for Human Subjects Research
- IRB SOP: Informed Consent Documentation for Human Subjects Research
- IRB SOP: Waiver or Alteration of the Informed Consent Process
- IRB SOP: Waiver or Alteration of Documentation of Consent
- IRB Investigator Manual
For more information please contact the IRB Office.
HIPAA and Human Subjects Research
If research will involve the use of Protected Health Information (PHI), criteria under the Health Insurance Portability and Accountability Act (HIPAA) may apply and the researcher will need to address how their research meets HIPAA requirements in the research submission.
Resources providing detailed information regarding the use of HIPAA information for research see:
Resources providing detailed information regarding the use of HIPAA information for research see:
- IRB Guidance: HIPAA and Human Subjects Research
- List of Protected Health Information (PHI) Identifiers
For more information please contact the IRB Office.